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Efficacy and safety of two administration modes of an intra‐detrusor injection of 750 units dysport® (abobotulinumtoxinA) in patients suffering from refractory neurogenic detrusor overactivity (NDO): A randomised placebo‐controlled phase IIa study
Author(s) -
Denys Pierre,
Del Popolo Giulio,
Amarenco Gerard,
Karsenty Gilles,
Le Berre Philippe,
Padrazzi Bruno,
Picaut Philippe
Publication year - 2017
Publication title -
neurourology and urodynamics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 90
eISSN - 1520-6777
pISSN - 0733-2467
DOI - 10.1002/nau.22954
Subject(s) - medicine , placebo , spinal cord injury , adverse effect , refractory (planetary science) , anesthesia , clinical endpoint , urology , detrusor muscle , urinary incontinence , quality of life (healthcare) , clinical trial , urinary bladder , spinal cord , physics , alternative medicine , nursing , pathology , psychiatry , astrobiology
Aims Assess the efficacy and safety of abobotulinumtoxinA (Dysport®) in adult patients with neurogenic detrusor overactivity (NDO). Methods This Phase IIa, international, multicentre, double‐blind, randomised, placebo controlled, pilot study enrolled 47 patients with NDO and urinary incontinence resulting from spinal cord injury (SCI) or multiple sclerosis (MS). Patients were treated with 15 intra‐detrusor injections of Dysport 750 U or the equivalent placebo (n = 16 and 7) or 30 injections of Dysport 750 U or the equivalent placebo (n = 17 and 7). Primary endpoint was change from baseline in mean number of daily incontinence episode frequency (IEF) at day 84. Secondary endpoints included change from baseline in urodynamic parameters and quality of life (QOL). A safety assessment was also conducted. Results Adjusted mean changes from baseline in IEF were −3.2 (−76%) and −1.7 (−15%) for 15 injections Dysport and placebo groups, respectively, ( P = 0.1103) and −3.2 (−88%) and −2.6 (−73%) for 30 injections Dysport and placebo groups, respectively, ( P = 0.0686). Statistically significant improvements in maximum cystometric capacity, maximum detrusor pressure and volume at first contraction were reported in the Dysport groups compared with placebo ( P < 0.05). Improvements in QOL were reported. Three muscle weakness episodes were reported as serious adverse events in two tetraplegic and one paraplegic patient, all in the 15 injections Dysport group. Conclusions Both 15 and 30 injections administration modes of Dysport decreased daily IEF and resulted in significant improvements in urodynamic parameters in NDO patients with MS or SCI. Reduction to 15 injection sites did not appear to be associated with any impact on efficacy. Neurourol. Urodynam. 36:457–462, 2017 . © 2016 Wiley Periodicals, Inc.